FDA grants approval to Moderna's mRNA flu vaccine for seniors

The U.S. Food and Drug Administration approved Moderna's mRNA seasonal influenza vaccine, named mFLUSIVA, for use in adults aged 50 and older for the 2026-2027 respiratory illness season. Clinical data showed the vaccine reduced confirmed flu cases by 27% in participants aged 50 to 64 compared with the standard vaccine, while safety profiles were similar, though mild side effects were reported more frequently and typically resolved within two days.

"Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America's seniors. This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation," said Stéphane Bancel, chief executive officer of Moderna.

For adults 65 and older, a high-dose flu vaccine is currently recommended. Moderna said it will monitor the vaccine's performance this winter against the high-dose product and will submit additional data to the FDA for continued approval in that age group.

The agency had previously declined to review Moderna's application but reversed its decision after the company agreed to conduct an additional study once the vaccine entered the market. The CDC continues to recommend annual flu vaccination for everyone six months of age and advises receiving the shot by the end of October.

Health officials have highlighted the mRNA platform’s ability to speed production and adapt to circulating virus strains, potentially improving vaccine match and availability.